Asacol Clinical Trial Recruitment

In conjunction with Procter & Gamble, Manning Selvage & Lee developed a campaign to help recruit people with ulcerative colitis (UC) into a clinical trial that was testing a higher dose formulation of P&G’s FDA-approved UC treatment, Asacol (mesalamine).

In conjunction with Procter & Gamble, Manning Selvage & Lee developed a campaign to help recruit people with ulcerative colitis (UC) into a clinical trial that was testing a higher dose formulation of P&G’s FDA-approved UC treatment, Asacol (mesalamine). UC is a chronic inflammation of the colon and rectum, often destroying a person’s quality of life. During a “flare,” sufferers may visit the bathroom as many as nine times a day or take as many as 16 pills a day to control the disease.

Asacol, considered a gold standard of UC treatment, reduces inflammation and helps keep the disease in remission. Even though there are 500,000 UC patients in the U.S, several factors whittled the recruitment pool far below that, making the finding of these patients equivalent to hunting for a needle in a haystack. Charged with the task of boosting enrollment among an elusive patient base, the PR team took several traditional and non-traditional approaches to drive patients to self-identify by seeking trial information.

Challenges

Two arms of the trial were initiated during January 2001 with the goal of recruiting 600 patients to just over 100 trial sites. By March, however, enrollment was below expectations and P&G decided to tap PR channels to reach these difficult to find patients. Several medical reasons for the low enrollment also created challenges for communications. One major obstacle was that because earlier studies showing the high-dose therapy had promising results, many physicians already put patients on the therapy off-label, making those patients ineligible. Additionally, at least 40% of UC patients aren’t compliant with their medication and some must temporarily resort to treating flares with steroids – another trial disqualifier. Perhaps the biggest challenge was that to qualify for the trial, the person’s UC had to be actively “in flare.”

In short, it was essential for PR to not only find these eligible patients, but to reach them at the right time. The PR Team had just six months to get the word out. If getting to the right patient at the right time wasn’t tricky enough, the Team was faced with the fact that media traditionally doesn’t cover the beginning of trials – especially not for drugs like Asacol that are in essence already FDA-approved. Further, media were also hesitant to cover a “below the belt” topic.

Research

Since the eligible patient was a “moving” target, the team conducted primary research to find out the best channels to reach them, interviewing UC patients, physicians, advocacy groups, leading UC research centers, and study coordinators to review recruiting methods. The team also conducted secondary research, including the gathering of latest medical literature on UC. These findings were used to help shape the strategy and develop compelling angles to make the media care about U.C. Key findings included:· UC is more prevalent in certain ethnic groups: According to the Crohn’s and Colitis Foundation of America (CCFA), the premier advocacy group for UC, there is a higher incidence of the disease in US- and European-born Jews. In fact, Ashkenazi Jews are two to eight times more likely to have inflammatory bowel diseases like ulcerative colitis than the general population. · UC starts young: According to the CCFA, the peak onset age of UC is 15-25. Twenty percent develop UC before the age of 20 · UC cases peak again at middle age: The incidence of first-onset UC spikes again between 50-65 years of age. Dr. David Sandborn of the Mayo Clinic noted that steroids and other harsh medications to control flares could be an issue among an older population because they may already be taking other types of medication.· UC patients use the Web: A thorough search of the Internet revealed that there were several personal, third party and institutional web sites actively dedicated to providing UC information. · UC dramatically effects a person’s quality of life: Talking to UC patients and looking at discussion boards on UC sites – the quality of life impact is clear: “depressed,” can’t work,” “constant pain and fatigue,” “missed school,” “embarrassed,” “isolated.”· UC hasn’t been widely covered by the media: A Lexis-Nexus search revealed that UC had not been covered extensively in national or local media. Reporter audits showed that many of them confused UC with the much less serious irritable bowel syndrome.

Planning

The research demonstrated that it was necessary to conduct targeted activities in order to get the trial information directly to the people who needed it most. The Team had uncovered several subgroups within the UC community that shared common traits other than UC, making them easier to find. There was a clear opportunity to engage organizations, segmented media and services that focus on these subgroups, to disseminate trial information. In order to keep the patient referral process centralized, the Team set up three channels for patient respone: 1) a 24-hour toll free line number that would screen callers and link eligible UC patients with the trial sites closest to them. 2) Trial site information was also set up on P&G’s consumer education UC web site, living-better.com 3) as well as the CCFA’s web site. Relationships with local investigators and patients were established early on so that the PR Team would be able to offer interviews with local media.

Objectives

· Drive at least 500 UC patients to the 1-800# · Increase the number of UC patients screened and help increase the number of patients enrolled in the trial · Reach at least 30 million people with messages about the trial, at least 50 percent of which were branded with the Asacol name

Strategic Approach

In order to reach a maximum number of UC patients, the PR Team needed to target specific sub-populations where they were most likely to be. To help overcome reporter resistance to covering the initiation of a trial, pitches were focused on the quality of life issues surrounding U.C.– and how the trial and study formulation of Asacol might help improve that.

Execution

The PR team embarked on a series of very targeted communications initiatives:.

The Jewish community: Leveraging the fact that some Jews were at higher risk for developing UC, the Team developed partnerships with several Jewish groups such as the Jewish Community Centers of America (JCCA) the Jewish Orthodox Movement who frequently educate their membership about genetic diseases. Information was provided to organizations with a request to include the 1-800# in their newsletters. The Team developed an e-mail alert about the trial and sent it to rabbis across the country.

Targeting synagogues in 15 cities, the Team sent posters with the 1-800# and a letter to rabbis asking that the posters be placed in high traffic areas. An article about UC prevalence and the trial, quoting Dr. Asher Kornbluth, the trial investigator at Mt. Sinai, was sent to regional Jewish magazines. These efforts yielded placements in the Los Angeles Jewish Journal and Washington Jewish Week . Information was posted at more than ten JCCA centers in cities like Atlanta, Pittsburgh and New York City.

The mature community: Working with Dr. Sandborn of the Mayo Clinic and a reporter at Senior Wire – a service that provides content for more than 50 senior community papers – the PR Team helped develop an article about the trial and UC in the older population. The PR Team developed a relationship with the Older Women’s League (OWL) and the same article appeared in the OWL Observer, a quarterly publication that reaches over 15,000 members, and was posted on the group’s web site. News about the trial appeared in publications such as New England Senior Beacon, 50+ Senior News and the Senior Beacon.

Young people: In order to reach young people, where UC usually first presents, the Team focused outreach in cities where there were universities. Campus papers were contacted and encouraged to interview the local investigator and a patient. The Team provided campus chapters of Hillel, the Jewish student organization, with an e-mail for sending to members and fliers for posting at the campus Hillel headquarters. A college-oriented press release that focused on the impact of UC on young people was sent across University Wire – a service that provides content for campus papers across the US. Finally, posters and trial information cards were placed in the bathrooms at the “Matzah Ball, “ a holiday party hosted by J-Date and attended by almost 2,000 young New York City professionals. Placements about the trial appeared in the Rutgers University Targum News, University of Virginia’s Cavalier Daily and Hillel chapters at universities in Cincinnati, Maryland and Miami posted information about the trial.

Those on the Web: The Team developed an e-mail about the trial from the study’s national lead investigator, Dr. Stephen Hanauer of the University of Chicago. This e-mail letter was posted on UC message boards, newsgroups and chat rooms several times a month on sites such as Google and Yahoo! The Team had carefully approached each site’s manager to ask permission to do the postings, so the e-mail wouldn’t be viewed negatively or removed. The same letter was used to send e-mails via an unlikely source – a web site called J-Date, which is an online Jewish-only dating site frequented by people ages 20-55. The Team worked with J-Date to have the e-mail sent to almost 17,000 of its members in trial site cities where there were other PR efforts taking place.

Local market media: Local media outreach was conducted in 25 cities in a series of waves to keep the news appearing over several weeks. In the first wave, community bulletins with the 1-800# and trial information were sent to calendar editors and radio PSA scripts, attributed to the local CCFA chapter were sent to radio stations. Next, the Team approached health/lifestyle reporters at newspapers to develop a feature story. Finally pitch team went full force to gain TV attention using a VNR, which focused on the life of a young UC patient and trial participant, as a hook. The VNR helped reporters see how they could craft a compelling story that included key trial messages and the 1-800# and resulted in placements in Houston, Baltimore, San Diego Miami with Chicago and New York scheduled. Print hits included the Arizona Republic, Dallas Morning News, and Detroit News.

Patients “in flare”: The 1-800# also captured the addresses of callers that would have pre-qualified for the trial except for the fact they were not in flare at the time of the call. To subsequently reach them, the team developed colorful “ reminder cards” that were mailed to the callers, directing them to call the 1-800# if they had a flare over the next few months.

In addition to the non-traditional tactics listed below, the PR team decided to balance its targeted communications efforts with more broad-scale controlled media initiatives—a VNR, ANR and mat release, all released nationally – to “fill in the blanks” in outreach and capture patients not in the specific targeted groups.

Summary of Results

The toll-free number received more than 800 calls in a five-month period between July and December.Through the toll-free number, more than 300 people pre-qualified for the trial. 187 people were enrolled between July and December. Total trial enrollment now stands at 330, which is 70% percent of goal, with 5 months remaining in the trial enrollment period.

Three of the four highest enrolling months – October, November and December—all followed specific PR initiatives

Targeted and local media efforts reached more than 45 million people, and 75% of placements included branded “Asacol” messages.